Manufacturers concerned about the proliferation of counterfeit drugs are working to implement serialized packaging to support full traceability, product integrity, supply-chain security and patient safety. Conventional serialization solutions multiplex cameras from an industrial PC to distribute vision at multiple points on the production line. Maintenance and validation can be expensive because of the need to deal with a complex operating system and custom software. Another challenge: cost and footprint required to serialize round, un-oriented bottles that frequently require positioning several cameras around the bottle in order to read the label.

Korber Medipak, a supplier of pharmaceutical serialization solutions, is looking to address such challenges with a serialization solution based on the use of smart cameras. Seidenader’s Process Manager line-level serialization software is designed to configure and manage the Cognex smart camera technology, reducing administration and validation expenses of vision technology. A single industrial PC at the line-level provides the recipe management, security and audit trailing for all camera stations on the packaging line, according to the company. Korber Medipak has also addressed the aggregation challenge of inspecting 2D codes on round bottles. With Process Manager 360, bottles can be read on-the-fly, capturing a 360-degree view of an un-oriented bottle. Due to the small footprint, the inspection station can be integrated anywhere on the packaging line; including the out-feed of a labeler, or in-feed of a bundler or case packer at speeds up to 400 bottles per minute.

Counterfeit pharmaceuticals are a real, global threat. The World Health Organization estimates that 10% to 15% of the world’s drug supply is fake, and in the US that figure is around 1%. Robert Bate, author of Phake: The Deadly World of Falsified and Substandard Medicines, estimates that more than 100,000 people are killed worldwide by counterfeit and substandard drugs every year. Recently counterfeit versions of the anti-cancer drug Avastin entered the supply chain in the United States and reached the hands of dozens of doctors across the United States.

Regulators around the world have been working for years to develop a standard for a secure electronic chain-of-custody for pharmaceuticals, often called ePedigree. Within a few years, ePedigree requirements are expected to impact all pharmaceutical plants worldwide. Even though all regions have not yet enacted ePedigree legislation, manufacturers exporting into regulated markets must adapt packaging to conform to specific regulations even when the product is produced in jurisdictions that have not yet imposed traceability requirements.

Nearly all pharmaceutical manufacturers are addressing these challenges by working on implementing serialization solutions that will affix a unique,traceable serial number on every package, bundle, case and pallet. This approach to accomplish an ePedigree solution will provide an electronic record of the entire product cycle that provides accurate and complete information about each transaction within the supply chain, making it possible to easily and quickly verify the authenticity of each pharmaceutical product.

Korber Medipak’s Seidenader subsidiary supplies serialization solutions for pharmaceutical packaging lines. Korber Medipak’s original serialization solutions use vision systems consisting of a camera, image processing card and image processing software running on an industrial PC. Industrial PC-based vision systems require IT department oversight, service pack updates, and other items like virus protection software. In addition, PC technology changes rapidly so that in as little as one year after installation, it can be difficult to source and configure a new PC with the same specifications as those currently used on the line.

The PC-based vision system used in the past took considerable time and effort to integrate because they required considerable vision expertise and possibly, knowledge of low-level programming languages. This can be very expensive because the path to serialization compliance remains unclear with current data formats and marking standards varying from country to country and region to region. Furthermore, production changes require possible code rewrites to the technology, and costly equipment upgrades to the packaging lines. The overall application software, hardware, and operating system for each vision system always require to be validated to meet FDA requirements, which is an expensive process in itself.

Seidenader worked with Cognex to develop a new serialization software solution taking advantage of In-Sight smart camera technology. The new line-level software requires only one PC per line to manage the security and recipes for the smart cameras, and audit trail all tool-set and threshold changes within the software itself. This solution provides reportedly involves lower cost of ownership because the vision operates independently of the computer operating system, is more stable over time and is not subject to yearly computer obsolescence. This approach reportedly makes it easy for the end-users to find “like for like” camera replacements for many years after initial installation, and to maintain consistent vision performance across multiple inspection points and packaging lines.

The Seidenader serialization solution requires much less effort on the part of the customer’s IT department when managing plant-wide computer updates and virus protection. It also is less expensive to implement because the Process Manager vision interface provides access to the tools that reduce the time and expertise required to develop the vision application and customize the solution to meet specific customer needs.

Process Manager standard verification inspections are designed to parse the data matrix serial number in real-time, automatically populating the human readable toolset and provide verification and match functionality. The vision I/O is managed via the Process Manager industrial computer platform, not a separate vision I/O board.

The Seidenader solution can provide item, bundle, case and/or pallet serialization throughout the packaging process. All serialization processes, equipment interfaces, printing stations, cameras and/or bar code readers are managed and controlled by Seidenader’s Process Manager software; ultimately creating and documenting the proper parent-child aggregation relationship at the line-level. Process Manager controls and maintains parent to child relationships, while associating and documenting the alias of each serial number along the way. A localized repository manages the real-time allocation of numbers, associations, and status updates as related to the batch.

Seidenader also provides browser-based site-level serialization software that provides the proper gateway between the packaging lines and the end-users ERP/MES environments. This software called MLS, interfaces with the L3 and L4 layers to manage client material master data and Production Orders automatically with the site-level serialization processes.

Seidenader has introduced a new 360 -egree inspection station with cost and complexity reportedly reduced by using only two Cognex DataMan 500 ID readers using the VSoC vision chip. VSoC technology enables DataMan 500 to offer unprecedented speeds on 1-D barcode reading with up to 90 decodes per second and ultrafast image acquisition with auto-exposure, at up to 1,000 frames per second.

By using a simple bar code reading architecture, engineered with a proprietary LED lighting and mirroring design, Process Manager 360 can verify data matrix codes printed on round bottles at high speeds, with minimal to no false rejects.

Process Manager 360 is based on an “open-view” design, so operators and mechanics can actually see the inspection process occur. Process Manager 360 requires minimal adjustment based on bottle height and diameter and can be maintained without specialized training.

Seidenader is working with several global pharmaceutical manufacturers to implement their new serialization solution and expects to have their first customers up and running early in 2013. “Customers are excited about utilizing our smart camera technology approach to help reduce the cost of implementing and maintaining serialization solutions,” Valeo said. “They are also excited about the dramatic reduction in cost and footprint for inspecting round bottles in complex aggregation applications. We are very pleased to be partnering with Cognex to deliver these benefits to the global pharmaceutical industry.”